Label: APLICARE POVIDONE-IODINE- povidone-iodine solution

  • NDC Code(s): 52380-0001-1, 52380-0001-3, 52380-0001-5
  • Packager: Aplicare Products, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated December 15, 2022

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  • Active Ingredient

    Povidone-iodine USP 10%

  • Purpose

    Antiseptic

  • Use

    antiseptic skin preparation

  • Warnings

    • For external use only
    • Avoid pooling beneath patient
    • Avoid excessive heat. Stre at room temperature

    Do not use

    • • if allergic to iodine
    • • in the eyes

    Ask doctor before use if injuries are

    • • deep or puncture wounds
    • • serious burns

    Stop use and ask a doctor if

    • • redness, irritation, swelling or pain persists or increases
    • • infection occurs

    Keep out of reach of children.

    In cas of accidental ingestion, seek professional assistance or consult a poison control center immediately.

  • Directions

    apply locally as needed

  • Other information

    • • 1% titratable iodine
    • • not made with natural rubber latex
    • • for hospital or professional use only
  • Inactive ingredients

    citric acid, disodium phosphate, nonoxynol-9, sodium hydroxide, water

  • Manufacturing Information

    Manufactured by:

    Aplicare Products, LLC.

    550 Research Parkway, Meriden,

    CT 06450 USA

    Made in USA

    1-800-633-5463

    0917

  • Package Label

    Rev 0917 Front

    Rev 0917 Back

    Rev V1 RI21APL

  • INGREDIENTS AND APPEARANCE
    APLICARE POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52380-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52380-0001-130 mL in 1 PACKET; Type 0: Not a Combination Product02/15/201803/31/2020
    2NDC:52380-0001-322.5 mL in 1 PACKET; Type 0: Not a Combination Product02/15/201805/31/2025
    3NDC:52380-0001-50.5 mL in 1 PACKET; Type 0: Not a Combination Product02/15/201807/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/01/198405/31/2025
    Labeler - Aplicare Products, LLC (081054904)
    Registrant - Medline Industries, LP (025460908)
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